Zysolin(TM) Improves Survival in Pivotal Animal Studies
Zysolin(TM) has demonstrated superior therapeutic efficacy in 2 pivotalanimal studies. In these lethality-based studies, Zysolin(TM) has consistentlyincreased survival rate by 50% over Tobramycin treatment group whereby allmice in the untreated group died within 24 hours after infection.
"P. aeruginosa is one of the most common and lethal pathogens responsiblefor ventilator-associated pneumonia in intubated patients, with directlyattributable death rates reaching 40%. "Reducing this mortality rate may bepossible, if a more effective therapy for the treatment of Pseudomonas VAP canbe developed," said Dr. Michael Weisspapir, MD, PhD, Chief Medical Scientistof AlphaRx. "If approved, Zysolin(TM) could be a first-in-class cell-targetednanomedicine which is designed to target intracellular pathogens that haveproven to be very difficult to eradicate clinically," further commented by Dr.Weisspapir.
AlphaRx is working with regulatory experts to devise a clinical plan forZysolin(TM) with a view to initiating Phase I human trials in early 2009.AlphaRx believes Zysolin(TM) may be eligible for an NDA submission under the505(b)(2) regulatory pathway, which permits companies to obtain FDA approvalof new drug applications (NDAs) by relying, in part, on the agency's findingsfor a previously approved drug. AlphaRx can potentially advance Zysolin(TM)rapidly through clinical testing and to commercialization using the 505(b)(2)pathway.
Zysolin(TM) is a Tobramycin compound, encapsulated in AlphaRx's Nano DrugDelivery Platform, intended for the adjunctive treatment of Gram-negativepneumonia in intubated and mechanically-ventilated patients. Zysolin(TM)improves the intracellular activity of Tobramycin - in layman's term,increasing the drug concentration of Tobramycin inside human macrophages, thusimproving its antibacterial activity against intracellular Klebsiella,Pseudomondas aeruginosa and Staphylococcus bacterial strains in pneumoniapatients. The active ingredient in Zysolin(TM), Tobramycin, has along-standing and proven clinical treatment record. Delivered by inhalation,using proprietary nanotechnology developed by AlphaRx, the company believesZysolin(TM) will have an attractive safety, tolerability and efficacy profilewhen compared to injectible Tobramycin.
About AlphaRx Inc.
AlphaRx is a specialty pharmaceutical company utilizing proprietarysite-specific nanoparticulate drug delivery systems to develop novelformulations of drugs that are insoluble or poorly soluble in water or haveyet to be administrable to the human body with an acceptable delivery method.
Forward Looking Statements:
This release contains forward-looking statements within the meaning andpursuant to the Safe Harbor provisions of the Securities Litigation Reform Actof 1995 and involve risks and uncertainties that may individually or mutuallyimpact the matters herein described, including but not limited to productdevelopment and acceptance, manufacturing, competition, regulatory and/orother factors, which are outside the control of the companies.
SOURCE AlphaRx Inc.
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